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Evaluating Panitumumab (ABX-EGF) Monotherapy in Patients With Metastatic Colorectal Cancer Following Treatment With Fluoropyrimidine, Irinotecan, and Oxaliplatin Chemotherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00083616
Recruitment Status : Completed
First Posted : May 28, 2004
Results First Posted : July 29, 2011
Last Update Posted : January 10, 2014
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Colorectal Cancer
Metastatic Cancer
Intervention Biological: Panitumumab
Enrollment 185
Recruitment Details Participants were enrolled from 1 March 2004 through 19 Jul 2006. Patient disposition is reported up until the data cut-off date of 22 December 2006. Completed study is defined as participants who either died on study or completed the safety follow-up visit (30 days after the last dose of panitumumab).
Pre-assignment Details  
Arm/Group Title Panitumumab (ABX-EGF)
Hide Arm/Group Description Open-label panitumumab administered by intravenous (IV) infusion at a dose of 6 mg/kg given once every 2 weeks until participants developed progressive disease, were unable to tolerate panitumumab, or discontinued treatment for other reasons.
Period Title: Overall Study
Started 185
Received Study Medication 182
Completed 154 [1]
Not Completed 31
Reason Not Completed
Disease Progression             16
Lost to Follow-up             1
Physician Decision             2
Withdrawal by Subject             3
Ineligibility determined             2
Non-compliance             1
Other             6
[1]
Completed safety followup or died on study as of the data cut-off date of 22 December 2006
Arm/Group Title Panitumumab
Hide Arm/Group Description Open-label panitumumab administered by intravenous (IV) infusion at a dose of 6 mg/kg given once every 2 weeks until participants developed progressive disease, were unable to tolerate panitumumab, or discontinued treatment for other reasons.
Overall Number of Baseline Participants 185
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 185 participants
59.6  (10.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 185 participants
Female
85
  45.9%
Male
100
  54.1%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 185 participants
American Indian or Alaska Native 0
Asian 4
Black or African American 15
Hispanic or Latino 19
Japanese 0
Native Hawaiian or Other Pacific Islander 1
White or Caucasian 144
Other 2
Aborigine 0
1.Primary Outcome
Title Number of Participants With Objective Tumor Response Through Week 16
Hide Description Confirmed objective tumor response (complete or partial response) based on modified World Health Organization (WHO) criteria, through week 16. Tumor response was assessed by a central Independent Review Committee (IRC) and confirmation 4 weeks after initial assessment was required. Complete Response (CR): Disappearance of all index and non-index lesions and no new lesions. Partial Response (PR): At least a 50% decrease in the sum of the product of the longest diameters (SPD) of index lesions taking as reference the Baseline SPD, and no new non-index lesions and no "unequivocal progression" of non-index lesions, or, the disappearance of all index lesions and persistence of one or more non-index lesions not qualifying for either CR or Progressive Disease.
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Adjudicated Prior Failures Set, composed of participants confirmed to be eligible by the Independent Eligibility Review Committee (IERC)
Arm/Group Title Panitumumab
Hide Arm/Group Description:
Open-label panitumumab administered by intravenous (IV) infusion at a dose of 6 mg/kg given once every 2 weeks until participants developed progressive disease, were unable to tolerate panitumumab, or discontinued treatment for other reasons.
Overall Number of Participants Analyzed 142
Measure Type: Number
Unit of Measure: Participants
5
2.Primary Outcome
Title Duration of Response
Hide Description The time from first objective response to first observed progression of disease or death if the death was due to disease progression (whichever comes first); participants who respond and have not progressed while on study or died for reasons other than disease progression while on study were censored at their last evaluable disease assessment date. Response (complete or partial response) was assessed per modified WHO criteria by the central IRC. Complete Response (CR): Disappearance of all index and non-index lesions and no new lesions. Partial Response (PR): At least a 50% decrease in the sum of the product of the longest diameters (SPD) of index lesions taking as reference the Baseline SPD, and no new non-index lesions and no "unequivocal progression" of non-index lesions, or, the disappearance of all index lesions and persistence of one or more non-index lesions not qualifying for either CR or Progressive Disease.
Time Frame Until the data cut-off date of 22 December 2006. Maximum time of follow-up was 128 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
Subset of the Adjudicated Prior Failures Set, composed of participants confirmed to be eligible by the Independent Eligibility Review Committee (IERC), who had a confirmed obective tumor response
Arm/Group Title Panitumumab
Hide Arm/Group Description:
Open-label panitumumab administered by intravenous (IV) infusion at a dose of 6 mg/kg given once every 2 weeks until participants developed progressive disease, were unable to tolerate panitumumab, or discontinued treatment for other reasons.
Overall Number of Participants Analyzed 5
Median (95% Confidence Interval)
Unit of Measure: Weeks
14.0
(12.4 to 101.7)
3.Secondary Outcome
Title Number of Participants With Objective Tumor Response Throughout Study
Hide Description Confirmed objective tumor response (complete or partial response) based on modified World Health Organization (WHO) criteria, throughout the duration of the study Tumor response was assessed by a central Independent Review Committee (IRC) and confirmation 4 weeks after initial assessment was required. Complete Response (CR): Disappearance of all index and non-index lesions and no new lesions. Partial Response (PR): At least a 50% decrease in the sum of the product of the longest diameters (SPD) of index lesions taking as reference the Baseline SPD, and no new non-index lesions and no "unequivocal progression" of non-index lesions, or, the disappearance of all index lesions and persistence of one or more non-index lesions not qualifying for either CR or Progressive Disease.
Time Frame Until the data cut-off date of 22 December 2006. Maximum time of follow-up was 128 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
Adjudicated Prior Failures Set, composed of participants confirmed to be eligible by the Independent Eligibility Review Committee (IERC)
Arm/Group Title Panitumumab
Hide Arm/Group Description:
Open-label panitumumab administered by intravenous (IV) infusion at a dose of 6 mg/kg given once every 2 weeks until participants developed progressive disease, were unable to tolerate panitumumab, or discontinued treatment for other reasons.
Overall Number of Participants Analyzed 142
Measure Type: Number
Unit of Measure: Participants
5
4.Secondary Outcome
Title Time to Response
Hide Description Median time from enrollment to objective tumor response for participants who responded.
Time Frame Until the data cut-off date of 22 December 2006. Maximum time of follow-up was 128 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
Subset of Adjudicated Prior Failures Set, composed of participants confirmed to be eligible by the Independent Eligibility Review Committee (IERC), who had a confirmed objective tumor response
Arm/Group Title Panitumumab
Hide Arm/Group Description:
Open-label panitumumab administered by intravenous (IV) infusion at a dose of 6 mg/kg given once every 2 weeks until participants developed progressive disease, were unable to tolerate panitumumab, or discontinued treatment for other reasons.
Overall Number of Participants Analyzed 5
Median (Inter-Quartile Range)
Unit of Measure: Weeks
11.0
(7.7 to 11.1)
5.Secondary Outcome
Title Progression-free Survival Time
Hide Description Kaplan-Meier estimate of median time from enrollment to death or first observed disease progression (whichever comes first). Participants who did not progress while on study and did not die while on study were censored at the last evaluable disease assessment date.
Time Frame Until the data cut-off date of 22 December 2006. Maximum follow-up time was 128 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
Adjudicated Prior Failures Set, composed of participants confirmed to be eligible by the Independent Eligibility Review Committee (IERC)
Arm/Group Title Panitumumab
Hide Arm/Group Description:
Open-label panitumumab administered by intravenous (IV) infusion at a dose of 6 mg/kg given once every 2 weeks until participants developed progressive disease, were unable to tolerate panitumumab, or discontinued treatment for other reasons.
Overall Number of Participants Analyzed 142
Median (95% Confidence Interval)
Unit of Measure: Weeks
7.3
(7.1 to 7.4)
6.Secondary Outcome
Title Time to Disease Progression
Hide Description Kaplan-Meier estimate of the median time from enrollment to first observed disease progression or death if death was due to disease progression (whichever comes first). Participants who did not progress while on study or died for reasons other than disease progression while on study were censored at their last evaluable disease assessment date.
Time Frame Until the data cut-off date of 22 December 2006. Maximum follow-up time was 128 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
Adjudicated Prior Failures Set, composed of participants confirmed to be eligible by the Independent Eligibility Review Committee (IERC)
Arm/Group Title Panitumumab
Hide Arm/Group Description:
Open-label panitumumab administered by intravenous (IV) infusion at a dose of 6 mg/kg given once every 2 weeks until participants developed progressive disease, were unable to tolerate panitumumab, or discontinued treatment for other reasons.
Overall Number of Participants Analyzed 142
Median (95% Confidence Interval)
Unit of Measure: Weeks
7.3
(7.1 to 7.6)
7.Secondary Outcome
Title Time to Treatment Failure
Hide Description Kaplan-Meier estimate of median time from enrollment to treatment failure, defined as the date the decision was made to end treatment. Participants remaining in the treatment phase at the time of the analysis were censored on their last visit date.
Time Frame Until the data cut-off date of 22 December 2006. Maximum follow-up time was 128 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
Adjudicated Prior Failures Set, composed of participants confirmed to be eligible by the Independent Eligibility Review Committee (IERC)
Arm/Group Title Panitumumab
Hide Arm/Group Description:
Open-label panitumumab administered by intravenous (IV) infusion at a dose of 6 mg/kg given once every 2 weeks until participants developed progressive disease, were unable to tolerate panitumumab, or discontinued treatment for other reasons.
Overall Number of Participants Analyzed 142
Median (95% Confidence Interval)
Unit of Measure: Weeks
8.0
(7.4 to 8.1)
8.Secondary Outcome
Title Duration of Stable Disease
Hide Description Kaplan-Meier estimates of the median time from enrollment to the date of first observed disease progression or death due to disease progression among those participants with a best outcome of stable disease. Stable disease (SD): Neither sufficient shrinkage of Index lesions to qualify for partial response nor sufficient increase to qualify for progressive disease (PD) taking as reference the nadir sum of the products of the longest diameters (SPD) since the treatment started and the disappearance of or persistence of one or more non-index lesions not qualifying for PD.
Time Frame Until the data cut-off date of 22 December 2006. Maximum follow-up time was 128 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
Subset of Adjudicated Prior Failures Set, composed of participants confirmed to be eligible by the Independent Eligibility Review Committee (IERC), with a best outcome of stable disease
Arm/Group Title Panitumumab
Hide Arm/Group Description:
Open-label panitumumab administered by intravenous (IV) infusion at a dose of 6 mg/kg given once every 2 weeks until participants developed progressive disease, were unable to tolerate panitumumab, or discontinued treatment for other reasons.
Overall Number of Participants Analyzed 31
Median (95% Confidence Interval)
Unit of Measure: Weeks
23.9
(23.0 to 31.0)
9.Secondary Outcome
Title Overall Survival
Hide Description Kaplan-Meier estimate of median time from enrollment to death from any cause. Deaths were recorded during treatment, safety follow-up and long term follow-up.
Time Frame Until the data cut-off date of 22 December 2006. Maximum follow-up time was 128 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
Adjudicated Prior Failures Set, composed of participants confirmed to be eligible by the Independent Eligibility Review Committee (IERC)
Arm/Group Title Panitumumab
Hide Arm/Group Description:
Open-label panitumumab administered by intravenous (IV) infusion at a dose of 6 mg/kg given once every 2 weeks until participants developed progressive disease, were unable to tolerate panitumumab, or discontinued treatment for other reasons.
Overall Number of Participants Analyzed 142
Median (95% Confidence Interval)
Unit of Measure: months
7.0
(5.7 to 8.0)
Time Frame From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
Adverse Event Reporting Description The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
 
Arm/Group Title Panitumumab
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
Panitumumab
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Panitumumab
Affected / at Risk (%)
Total   62/182 (34.07%) 
Blood and lymphatic system disorders   
Anaemia  1  1/182 (0.55%) 
Cardiac disorders   
Atrial fibrillation  1  1/182 (0.55%) 
Cardiac failure congestive  1  1/182 (0.55%) 
Gastrointestinal disorders   
Abdominal distension  1  3/182 (1.65%) 
Abdominal hernia  1  1/182 (0.55%) 
Abdominal pain  1  4/182 (2.20%) 
Abdominal pain lower  1  1/182 (0.55%) 
Ascites  1  3/182 (1.65%) 
Colonic fistula  1  1/182 (0.55%) 
Constipation  1  1/182 (0.55%) 
Diarrhoea  1  1/182 (0.55%) 
Duodenal obstruction  1  1/182 (0.55%) 
Gastrointestinal haemorrhage  1  1/182 (0.55%) 
Intestinal obstruction  1  2/182 (1.10%) 
Nausea  1  2/182 (1.10%) 
Pancreatitis  1  1/182 (0.55%) 
Pancreatitis acute  1  1/182 (0.55%) 
Reflux oesophagitis  1  1/182 (0.55%) 
Small intestinal obstruction  1  6/182 (3.30%) 
Vomiting  1  2/182 (1.10%) 
General disorders   
Early satiety  1  1/182 (0.55%) 
Fatigue  1  1/182 (0.55%) 
Pain  1  1/182 (0.55%) 
Hepatobiliary disorders   
Bile duct obstruction  1  2/182 (1.10%) 
Cholangitis  1  1/182 (0.55%) 
Hepatic function abnormal  1  1/182 (0.55%) 
Hyperbilirubinaemia  1  1/182 (0.55%) 
Jaundice cholestatic  1  1/182 (0.55%) 
Immune system disorders   
Hypersensitivity  1  1/182 (0.55%) 
Infections and infestations   
Bacteraemia  1  1/182 (0.55%) 
Catheter related infection  1  1/182 (0.55%) 
Cellulitis  1  1/182 (0.55%) 
Endocarditis staphylococcal  1  1/182 (0.55%) 
Folliculitis  1  1/182 (0.55%) 
Lobar pneumonia  1  1/182 (0.55%) 
Pneumonia  1  3/182 (1.65%) 
Pneumonia bacterial  1  1/182 (0.55%) 
Pyelonephritis  1  1/182 (0.55%) 
Septic embolus  1  1/182 (0.55%) 
Septic shock  1  1/182 (0.55%) 
Urosepsis  1  1/182 (0.55%) 
Injury, poisoning and procedural complications   
Humerus fracture  1  1/182 (0.55%) 
Lumbar vertebral fracture  1  1/182 (0.55%) 
Investigations   
Weight decreased  1  1/182 (0.55%) 
Metabolism and nutrition disorders   
Cachexia  1  1/182 (0.55%) 
Dehydration  1  2/182 (1.10%) 
Diabetes mellitus inadequate control  1  1/182 (0.55%) 
Fluid retention  1  1/182 (0.55%) 
Hyperkalaemia  1  1/182 (0.55%) 
Hypocalcaemia  1  1/182 (0.55%) 
Hypokalaemia  1  2/182 (1.10%) 
Hypomagnesaemia  1  1/182 (0.55%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Colon cancer  1  6/182 (3.30%) 
Colon cancer metastatic  1  6/182 (3.30%) 
Colorectal cancer  1  5/182 (2.75%) 
Metastases to central nervous system  1  1/182 (0.55%) 
Neoplasm progression  1  1/182 (0.55%) 
Rectal cancer metastatic  1  2/182 (1.10%) 
Nervous system disorders   
Anoxic encephalopathy  1  1/182 (0.55%) 
Convulsion  1  2/182 (1.10%) 
Dizziness  1  1/182 (0.55%) 
Hepatic encephalopathy  1  1/182 (0.55%) 
Speech disorder  1  1/182 (0.55%) 
Spinal cord compression  1  1/182 (0.55%) 
Vocal cord paralysis  1  1/182 (0.55%) 
Psychiatric disorders   
Anxiety  1  2/182 (1.10%) 
Confusional state  1  1/182 (0.55%) 
Respiratory, thoracic and mediastinal disorders   
Acute respiratory failure  1  1/182 (0.55%) 
Bronchial obstruction  1  1/182 (0.55%) 
Dyspnoea  1  7/182 (3.85%) 
Hypoxia  1  2/182 (1.10%) 
Pleural effusion  1  3/182 (1.65%) 
Pneumothorax  1  1/182 (0.55%) 
Pulmonary embolism  1  1/182 (0.55%) 
Pulmonary oedema  1  1/182 (0.55%) 
Respiratory arrest  1  1/182 (0.55%) 
Respiratory distress  1  1/182 (0.55%) 
Respiratory failure  1  4/182 (2.20%) 
Vascular disorders   
Circulatory collapse  1  1/182 (0.55%) 
Deep vein thrombosis  1  3/182 (1.65%) 
Hypotension  1  1/182 (0.55%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Panitumumab
Affected / at Risk (%)
Total   176/182 (96.70%) 
Gastrointestinal disorders   
Abdominal pain  1  34/182 (18.68%) 
Ascites  1  11/182 (6.04%) 
Constipation  1  36/182 (19.78%) 
Diarrhoea  1  48/182 (26.37%) 
Dyspepsia  1  12/182 (6.59%) 
Nausea  1  58/182 (31.87%) 
Stomatitis  1  16/182 (8.79%) 
Vomiting  1  38/182 (20.88%) 
General disorders   
Asthenia  1  12/182 (6.59%) 
Chills  1  11/182 (6.04%) 
Fatigue  1  66/182 (36.26%) 
Oedema peripheral  1  17/182 (9.34%) 
Pyrexia  1  23/182 (12.64%) 
Infections and infestations   
Paronychia  1  32/182 (17.58%) 
Rash pustular  1  16/182 (8.79%) 
Urinary tract infection  1  13/182 (7.14%) 
Investigations   
Weight decreased  1  19/182 (10.44%) 
Metabolism and nutrition disorders   
Anorexia  1  31/182 (17.03%) 
Decreased appetite  1  11/182 (6.04%) 
Dehydration  1  12/182 (6.59%) 
Hypokalaemia  1  15/182 (8.24%) 
Hypomagnesaemia  1  20/182 (10.99%) 
Musculoskeletal and connective tissue disorders   
Back pain  1  21/182 (11.54%) 
Pain in extremity  1  10/182 (5.49%) 
Nervous system disorders   
Dizziness  1  12/182 (6.59%) 
Headache  1  18/182 (9.89%) 
Psychiatric disorders   
Anxiety  1  14/182 (7.69%) 
Depression  1  10/182 (5.49%) 
Insomnia  1  16/182 (8.79%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  24/182 (13.19%) 
Dyspnoea  1  29/182 (15.93%) 
Skin and subcutaneous tissue disorders   
Acne  1  10/182 (5.49%) 
Dermatitis acneiform  1  125/182 (68.68%) 
Dry skin  1  28/182 (15.38%) 
Erythema  1  112/182 (61.54%) 
Exfoliative rash  1  30/182 (16.48%) 
Nail disorder  1  15/182 (8.24%) 
Pruritus  1  96/182 (52.75%) 
Rash  1  44/182 (24.18%) 
Rash papular  1  12/182 (6.59%) 
Skin exfoliation  1  17/182 (9.34%) 
Skin fissures  1  24/182 (13.19%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Amgen Inc.
Phone: 866-572-6436
Layout table for additonal information
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00083616    
Obsolete Identifiers: NCT00087243
Other Study ID Numbers: 20030167
First Submitted: May 26, 2004
First Posted: May 28, 2004
Results First Submitted: August 6, 2010
Results First Posted: July 29, 2011
Last Update Posted: January 10, 2014